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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06690086




Registration number
NCT06690086
Ethics application status
Date submitted
13/11/2024
Date registered
15/11/2024
Date last updated
15/11/2024

Titles & IDs
Public title
DermaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer
Scientific title
DERMaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer
Secondary ID [1] 0 0
CSP-18-0002
Universal Trial Number (UTN)
Trial acronym
DERM-SUCCESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Lesion biopsy
Treatment: Devices - DermaSensor Device Use

Subjects with skin lesions suggestive of skin cancer - Subjects with primary skin lesion(s) suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma requiring biopsy to assess the DermaSensor device accuracy in determining risk of malignancy.


Treatment: Surgery: Lesion biopsy
Lesions enrolled in the study are biopsied to confirm histopathology

Treatment: Devices: DermaSensor Device Use
Users are blinded to the DermaSensor Device result
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sensitivity of DermaSensor for abnormal skin lesion detection
Timepoint [1] 0 0
Day 0
Primary outcome [2] 0 0
Sensitivity + Specificity > 1 for abnormal skin lesion detection by DermaSensor
Timepoint [2] 0 0
Day 0
Secondary outcome [1] 0 0
Non-inferiority of the DermaSensor sensitivity to the performance goal of 90%
Timepoint [1] 0 0
Day 0

Eligibility
Key inclusion criteria
1. Men or women of any ethnic group aged 22 and older
2. Primary skin lesion suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma that requires biopsy to assess risk of malignancy
3. Patient is willing and able to read, understand and sign the ICF
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Lesion < 2.5mm in diameter or > 15mm in diameter
2. Lesion surface not accessible (e.g. inside ears, under nails, completely covered by a crust or scale)
3. Lesion on area of crust, psoriasis, eczema or similar skin condition
4. Lesion has erosion and/or ulceration with no area >2.5mm intact
5. Lesion has foreign matter (e.g. tattoo, splinter, dermoscopy oils, or other medicated or non-medicated topical solutions)
6. Lesion in which the device tip cannot be placed entirely within the border of the targeted area
7. Lesion located on acral skin (e.g. sole or palms)
8. Lesion located within 1 cm of the eye
9. Lesion on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention
10. Lesion located on mucosal surfaces (e.g. genitals, lips)
11. Lesion located on acute sunburn
12. Six (6) or more lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma requiring biopsy to assess risk of malignancy
13. Dementia or other neurologic, physical or psychological limitation that would prevent the patient from signing informed consent

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/12/2021
Sample size
Target
Accrual to date
Final
1021
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Clare Medical Center - Clare
Recruitment postcode(s) [1] 0 0
5453 - Clare
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Minnesota

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
DermaSensor, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Mayo Clinic
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the clinical validity of the proprietary DermaSensor ESS device and classifier algorithm to support assessment of skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in the primary care setting.
Trial website
https://clinicaltrials.gov/study/NCT06690086
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen P Merry, MD, MPH
Address 0 0
Mayo Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06690086